Who is sponsoring NCT01446289?

NCT01446289 is sponsored by Novartis.

What condition does NCT01446289 study?

NCT01446289 studies Streptococcal Infection, Gram-positive Bacterial Infection, Bacterial Infection.

What drugs are being tested in NCT01446289?

Interventions: Group B Streptococcus Trivalent Vaccine, Placebo.

What is the status of NCT01446289?

NCT01446289 is currently COMPLETED.

Last reviewed 2014-09-05 · How we verify

A Phase II Randomized, Observer-Blind, Multi-Center, Controlled Study of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women

NCT01446289 Phase 2 COMPLETED Results posted

The study investigated the immune response induced by the Group B streptococcus vaccine in healthy pregnant women. In addition, the study investigated the amount of vaccine induced antibodies which were transferred to the newborn.

Details

Lead sponsor	Novartis
Phase	Phase 2
Status	COMPLETED
Enrolment	86
Start date	2011-09
Completion	2013-10

Conditions

Streptococcal Infection
Gram-positive Bacterial Infection
Bacterial Infection

Interventions

Group B Streptococcus Trivalent Vaccine
Placebo

Primary outcomes

Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth — Day of delivery/birth
GMCs of anti-Group B Streptococcus (GBS) capsular polysaccharide (CPS) antibodies against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.
Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery — Day of delivery/birth
The Geometric mean transfer ratio of anti-GBS CPS antibodies against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.

Countries

Belgium, Canada